Associate Manager, Quality Assurance

Stryker Corporation; Irvine (CA); Hybrid; USD 118,000 - 197,000; Full time

Job summary

Stryker Corporation in Irvine, CA is hiring an Associate Manager of Quality Assurance to lead a high-performing Quality Operations team and drive quality excellence across manufacturing and business functions. You will oversee compliance, CAPAs, audits, and continuous improvement initiatives, shaping a culture of accountability and quality ownership.

The role requires a Bachelor’s degree in engineering or science and 6+ years in a regulated environment, with expertise in SPC, FMEA, RCA, and

Qualifications

• Bachelor's degree in Engineering or Science required.
• 6+ years in a regulated manufacturing environment.
• Expert working knowledge of regulatory requirements and audits.
• Experience with quality tools (SPC, FMEA, RCA, Poka-Yoke).

Responsibilities

• Lead and develop a Quality Engineering team, providing guidance and support to manufacturing and cross-functional partners while promoting a culture of quality and continuous improvement.
• Ensure products, processes, and systems comply with Stryker quality standards, regulatory requirements, and customer expectations.
• Foster an inclusive, engaged, and high-performing team environment through coaching, development, and effective employee relations practices.
• Recruit, develop, and retain talent, aligning team strengths with business needs and future growth opportunities.
• Partner with site leaders and functional teams to establish, maintain, and improve quality systems, standards, and compliance processes.
• Support internal, external, and regulatory audits, helping maintain site certifications and inspection readiness.
• Oversee investigations, nonconformances, CAPAs, and product/process deviations, ensuring timely resolution and effective risk mitigation.
• Monitor quality performance metrics and drive quality improvement initiatives that enhance product quality, reduce risk, improve efficiency, and support site and global business objectives.

Skills

Regulatory knowledge

Quality improvement

Team leadership

Education

Bachelor's degree in Engineering or Science

Tools

SPC / Process Control

FMEA

Root Cause Analysis

Poka-Yoke

Job description

## Associate Manager, Quality AssuranceApply: Irvine, California: Full time: Posted Today: R574840Work Flexibility: Onsite**Stryker** is hiring an **Associate Manager, Quality Assurance** in **Irvine, CA** to lead a high-performing Quality Operations team and drive quality excellence across manufacturing and business functions. In this role, you will provide leadership and direction for quality assurance activities with a strong focus on compliance, risk prevention, continuous improvement, and operational effectiveness. You will be responsible for ensuring adherence to Stryker Corporate and SGS requirements, Quality System Regulations, and applicable industry standards while fostering a culture of engagement, accountability, and quality ownership. This position plays a key role in delivering both compliance and business objectives, supporting product quality, process improvements, and overall organizational success.**What you will do:*** Lead and develop a Quality Engineering team, providing guidance and support to manufacturing and cross-functional partners while promoting a culture of quality and continuous improvement.* Ensure products, processes, and systems comply with Stryker quality standards, regulatory requirements, and customer expectations.* Foster an inclusive, engaged, and high-performing team environment through coaching, development, and effective employee relations practices.* Recruit, develop, and retain talent, aligning team strengths with business needs and future growth opportunities.* Partner with site leaders and functional teams to establish, maintain, and improve quality systems, standards, and compliance processes.* Support internal, external, and regulatory audits, helping maintain site certifications and inspection readiness.* Oversee investigations, nonconformances, CAPAs, and product/process deviations, ensuring timely resolution and effective risk mitigation.* Monitor quality performance metrics and drive quality improvement initiatives that enhance product quality, reduce risk, improve efficiency, and support site and global business objectives.**What you need:****Required*** Bachelors degree in Engineering or Science related discipline.* Minimum of 6+ years’ experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.* Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by governing and/or regulatory bodies.* Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, or other Six Sigma tools.**Preferred*** Experience working within FDA-regulated medical device, pharmaceutical, or life sciences environments preferred.* Business Management or MBA is an advantage.* Demonstrated success in building, leading, and developing high-performing, engaged teams is preferred.* Demonstrated ability to execute organizational and functional strategies while leading and driving change initiatives, with a proven track record of influencing and implementing change at both the individual and team levels.$118,000 - $196,600 USD AnnualTravel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.